Masimo has received FDA 510(k) clearance for atrial fibrillation detection on its Radius VSM monitor, reporting 97% sensitivity and 100% specificity in clinical validation. The feature joins an earlier-cleared respiratory depression algorithm, extending pulse oximetry into automated recognition of clinically important physiological patterns.
European regulators have recommended extending TRYNGOLZA to adults with fasting triglycerides of at least 880 mg/dL. The decision follows two Phase 3 trials demonstrating substantial triglyceride reductions and 85% fewer adjudicated acute pancreatitis events in a pooled analysis.
Estuary Biotherapeutics has launched with $103 million in committed financing to develop kidney-targeted gene therapies for autosomal dominant polycystic kidney disease. Its two lead programmes target PKD2 and PKD1 mutations, building on mouse research suggesting that restoring polycystin activity can reverse some features of established kidney disease.
The EMA's CHMP has maintained its negative opinion on narsoplimab for transplant-associated thrombotic microangiopathy, citing unresolved clinical evidence concerns. Omeros disputes aspects of the re-examination and is shifting attention toward US commercialization and alternative patient access arrangements.
The FDA has approved satralizumab for adults with thyroid eye disease, introducing the first at-home subcutaneous treatment option. The decision follows two Phase 3 trials, one of which missed its primary endpoint, while the other demonstrated significant improvements in eye bulging and double vision.
Organon has reported a cumulative six-year Pearl Index of 0.93 and an estimated pregnancy rate of 3.9% for the hormone-free MIUDELLA intrauterine system. The findings support an FDA application to extend its approved use from three to six years, with a decision expected in the second quarter of 2027.
Virion Therapeutics will present extended Phase 1b follow-up for VRON-0200 at AASLD 2026. Earlier published results showed continued hepatitis B surface antigen declines in most patients receiving the experimental immunotherapy alone, but a functional cure has not been established.
Palleon Pharmaceuticals will present interim Phase 2 results for HLX79 plus a rituximab biosimilar in membranous nephropathy. A publicly available abstract reports 17 remissions among 26 patients, although the blinded analysis includes patients receiving rituximab without HLX79.
China's NMPA has authorized clinical investigation of NW001, a PD-L1-targeted antibody conjugate carrying a histone deacetylase inhibitor. Chipscreen reports activity in checkpoint-resistant preclinical cancer models, but human safety, dosing and efficacy remain unestablished.
A peer-reviewed validation study found that patients with high OncoPrism-NSCLC scores had a 71% response rate to checkpoint inhibitor-based treatment, compared with 36% in lower-scoring groups. The analysis included 1,487 patients across four datasets, although the prospective clinical utility of using the test to choose treatment remains unproven.